• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall One Touch

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Recall
One Touch
see related information
Date Posted January 05, 2007
Recall Status1 Terminated on June 06, 2007
Recall Number Z-0266-2007
Recall Event ID 36863
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
Code Information One Touch Basic/Profile Lot #''s 2606340, 2619932, 272894A, 2615211 One Touch Ultra Lot #''s 2691191, 2691261
Recalling Firm/
Manufacturer
Core Care Technologies, Inc
309 Fries Mill Rd., Suite 14
Sewell, New Jersey 08080
For Additional Information Contact Ronald Manno
856-218-2476
Manufacturer Reason
for Recall
Counterfeit product (manufacturer unknown)
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit
Action The firm identified the customers who had been sent OneTouch test strips since August 2006 and contacted each by phone to identify the lot number of the test strips in the customer's possession. A letter was sent on 11/21/2006 by first class mail which identified the lot numbers identified in the letter from the law firm and providing instructions to follow if the affected lots were found.
Quantity in Commerce unknown
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-